Table 1.
Demographics and other baseline characteristics (ITT population).
| Total (N = 339) | |
|---|---|
| Mean age, years (SD) | 7.4 (2.09) |
| Sex, male, (%) | 220 (65) |
| Race, % | |
| Caucasian | 256 (76) |
| African American | 60 (18) |
| Asian | 14 (4) |
| Other | 9 (3) |
| Mean duration of asthma, years (SD) | 4.6 (2.52) |
| Allergy history | |
| No allergies, n (%) | 135 (40) |
| One or more allergies | 203 (60) |
| Number of subjects reporting exacerbations in the prior year, n (%)a | |
| Requiring hospitalization | 25 (7) |
| Requiring oral corticosteriods | 331 (98) |
| Type of school | |
| Traditional, not started at randomization | 309 (91) |
| Traditional, started when randomized | 14 (4) |
| Daycare | 11 (3) |
| Year-round, not started at randomization | 1 (<1) |
| Year-round, started when randomized | 4 (1) |
a
An exacerbation was defined per the protocol as a deterioration of asthma that required the use of outpatient SCS (tablets, suspensions, or injection) or an urgent care visit, hospitalization, or emergency room visit; ITT, intent-to-treat; SCS, systemic corticosteroid; SD, standard deviation.